Events

Retiro De Equipo (Recall) de Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Allergan.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58574
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2123-2011
  • Fecha de inicio del evento
    2011-03-21
  • Fecha de publicación del evento
    2011-05-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99617
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implant, intragastric for morbid obesity - Product Code LTI
  • Causa
    The recall was initiated because allergan has determined that a number of access port needle pouches from one specific lot number may have small gaps in a pouch seal. consequently the product may no longer be sterile.
  • Acción
    Allegan sent an Urgent Medical Device Recall letter dated March 21, 2011, to all affected customers. Allergan requested that upon receipt of letter, that the customer check their existing inventory of product for affected lot. Customers were requested to complete Business Reply Card, stating quantity of inventory of affected lot, if any, and return to Allergan Medical. Customer with remaining inventory were instructed to contact Allergan Medical Product Support at 1-800-624-4261, x5972 or 1-805-961-5972 for return and immediate replacement. . Customers will be issued credit for returned product. For questions regarding this recall call 805-319-0589.

Device

Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
  • Modelo / Serial
    Lot Number: 9L01 N
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, MN, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Australia, Canada, Germany, Great Britian, and the Netherlands
  • Descripción del producto
    Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N || 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.
  • Manufacturer
    Allergan

Manufacturer

Allergan